Nasal airway tissue treatment system and method

Abstract

A method for treating a nasal airway to ameliorate one or more symptoms of rhinitis in a patient may involve activating a radiofrequency console attached to a stylus, bending a shaft of the stylus in at least one location to a desired angle, advancing a distal tip of the radiofrequency stylus into a nostril of the patient, applying pressure against nasal mucosa lining the nasal airway with a treatment surface of the distal tip, and delivering radiofrequency energy from one set of bipolar electrodes on the treatment surface of the distal tip to a second set of bipolar electrodes on the treatment surface, to treat tissue underlying the nasal mucosa, including at least one nasal nerve. The method may also involve contacting the distal tip with an additional tissue at another location and delivering radiofrequency energy to the additional tissue.

We claim: 
     
         1 . A kit for treating nasal airway tissue to ameliorate one or more symptoms of rhinitis, the kit comprising:
 a console, comprising:
 a housing; 
 a radiofrequency energy generator in the housing; 
 a computer processor in the housing; and 
 an outlet on the housing; 
   a stylus, comprising:
 a handle; 
 a power cord connected to a first end of the handle, the power cord including a connector at an opposite end for connecting to the outlet; 
 a shaft extending from a second end of the handle; and 
 a distal tip extending from a distal end of the shaft, the distal tip comprising:
 a treatment surface; 
 two rows of bipolar radiofrequency electrodes on the treatment surface; and 
 a temperature sensing member on the treatment surface; and 
 
   at least one additional component selected from the group consisting of a packet of conductive gel, a curved anesthesia needle, a shaft bending tool and instructions for use.   
     
     
         2 . The kit of  claim 1 , wherein the shaft of the stylus is malleable and has a width of 4 millimeters to 5 millimeters. 
     
     
         3 . The kit of  claim 1 , wherein each of the two rows of bipolar radiofrequency electrodes comprises four electrodes, and wherein the electrodes are protruding, non-piercing electrodes. 
     
     
         4 . The kit of  claim 1 , wherein the treatment surface is convex. 
     
     
         5 . The kit of  claim 1 , wherein the shaft of the stylus has a length of 3.75 inches, and wherein the kit further comprises an additional stylus having a shaft with a length of less than 3 inches. 
     
     
         6 . The kit of  claim 1 , further comprising:
 a power cord coupled with the console;   a foot pedal attachable to the console for activating the console to supply radiofrequency energy to the stylus; and   an on/off button on the stylus for activating the console to supply the radiofrequency energy to the stylus.   
     
     
         7 . The kit of  claim 1 , further comprising a foot pedal attachable to the console for activating the console to supply radiofrequency energy to the stylus, wherein the console is configured to receive a reset signal from the foot pedal to reset the console after an error message. 
     
     
         8 . The kit of  claim 1 , wherein the shaft bending tool is configured to bend the shaft at only one location along the shaft and prevents bending of the shaft beyond a predefined maximum bending angle. 
     
     
         9 . A method for treating a nasal airway to ameliorate one or more symptoms of rhinitis in a patient, the method comprising:
 activating a radiofrequency console attached to a stylus;   bending a shaft of the stylus in at least one location to a desired angle;   advancing a distal tip of the radiofrequency stylus into a nostril of the patient;   applying pressure against nasal mucosa lining the nasal airway with a treatment surface of the distal tip;   delivering radiofrequency energy from one set of bipolar electrodes on the treatment surface of the distal tip to a second set of bipolar electrodes on the treatment surface, to treat tissue underlying the nasal mucosa, wherein the tissue comprises at least one nasal nerve;   contacting the distal tip with an additional tissue in another location within the nasal airway;   delivering radiofrequency energy to the additional tissue; and   removing the distal tip of the stylus from the nostril.   
     
     
         10 . The method of  claim 9 , further comprising:
 moving the distal tip to multiple additional locations within the nasal airway; and   delivering radiofrequency energy to nasal airway tissue at the multiple additional locations.   
     
     
         11 . The method of  claim 10 , wherein the console automatically stops delivering radiofrequency energy to the stylus after a maximum total number of treatments has been reached for the patient, and wherein the maximum total number of treatments is in a range from 16 to 24 treatments. 
     
     
         12 . The method of  claim 9 , wherein delivering the radiofrequency energy comprises delivering the energy for 12 seconds. 
     
     
         13 . The method of  claim 9 , further comprising sensing a temperature of the nasal mucosa with a temperature sensing member located on the treatment surface of the distal tip. 
     
     
         14 . The method of  claim 13 , further comprising automatically shutting off delivery of radiofrequency energy from the console to the stylus if the sensed temperature is above a predefined acceptable maximum temperature. 
     
     
         15 . The method of  claim 9 , wherein the at least one nasal nerve comprises a posterior nasal nerve. 
     
     
         16 . The method of  claim 9 , wherein bending the shaft comprises bending the shaft at a first location within one inch of the distal tip. 
     
     
         17 . The method of  claim 16 , wherein bending the shaft further comprises bending the shaft at a second location between one half and one third of a total length of the shaft, measured from a connection point of the shaft with a handle of the stylus. 
     
     
         18 . The method of  claim 9 , further comprising injecting an anesthetic fluid into the nasal mucosa before advancing the distal tip of the stylus into the nostril, to enhance conduction of the delivered radiofrequency energy through the mucosal tissue. 
     
     
         19 . The method of  claim 9 , wherein delivering the radiofrequency energy ablates the at least one nasal nerve. 
     
     
         20 . The method of  claim 9 , wherein the additional tissue is selected from the group consisting of an inferior turbinate, a middle turbinate, a superior turbinate, a nasal septum, and a septal swell body. 
     
     
         21 . The method of  claim 9 , wherein bending the shaft is performed before activating the radiofrequency console. 
     
     
         22 . A device for treating nasal airway tissue to ameliorate one or more symptoms of rhinitis, the device comprising:
 a handle;   a power cord connected to a first end of the handle and including a connector at an opposite end for connecting to an outlet of a radiofrequency console;   a shaft extending from a second end of the handle;   a distal tip extending from a distal end of the shaft, the distal tip comprising:
 a treatment surface; 
 two rows of bipolar radiofrequency electrodes on the treatment surface; and 
 a temperature sensing member on the treatment surface; and 
   an expandable treatment member configured to be advanced out of a distal end of the shaft, wherein the expandable treatment member comprises at least one pair of bipolar radiofrequency electrodes.   
     
     
         23 . The device of  claim 22 , wherein the shaft of the stylus is malleable and has a width of 4 millimeters to 5 millimeters. 
     
     
         24 . The device of  claim 22 , wherein the expandable treatment member comprises an expandable wire component disposed in a lumen of the shaft of the stylus when not in use and is advanced out of the lumen, over the distal tip of the stylus, to allow the expandable treatment member to expand for use in treatment. 
     
     
         25 . The device of  claim 22 , wherein the expandable treatment member comprises an expandable wire component disposed in a lumen of the shaft of the stylus when not in use and is advanced out of the lumen, through an opening in the distal tip of the stylus, to allow the expandable treatment member to expand for use in treatment. 
     
     
         26 . The device of  claim 22 , The device of  claim 22 , wherein the expandable treatment member comprises cryotherapy balloon disposed in a lumen of the shaft of the stylus when not in use and is advanced out of the lumen, over the distal tip of the stylus, to allow the cryotherapy balloon to be inflated for use in treatment.